MAUDE Adverse Event Report: 3M HEALTH CARE 3M STERI-STRIP REINFORCED SKIN CLOSURES; STERI-STRIP SKIN CLOSURES

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Rash (2033); Skin Discoloration (2074); Skin Inflammation/ Irritation (4545)

Event Date 04/12/2021

Event Type  Injury  

Manufacturer Narrative

There is no evidence supporting contributory causation to hypopigmentation by the 3m steri-strip reinforced adhesive skin closure.A sample was not available for return and a lot number was not provided.A medical complaint history review was completed for 3m steri-strip reinforced adhesive skin closures from april 1, 2019 - april 30, 2021.No trend was observed.Complaints will continue to be monitored.End of report.

Event Description

A rash with hives and itchiness and skin hypopigmentation was reported at the incision site on a rib where one 3m¿ steri-strip¿ reinforced adhesive skin closure was applied after a rhinoplasty was performed.The symptoms were observed about one week after the surgery, and betamethasone 0.1% ointment was prescribed and applied three times a day for four days.The symptoms resolved except for the hypopigmented area.The surgical incision is healing.

• Brand Name: 3M STERI-STRIP REINFORCED SKIN CLOSURES
• Type of Device: STERI-STRIP SKIN CLOSURES
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY BROOKINGS; 601 22nd ave south; brookings SD 57006
• Manufacturer Contact: dianne gibbs ; 3m center building 275-5w-06; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 11810264
• MDR Text Key: 250228193
• Report Number: 2110898-2021-00030
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 30707387023646
• UDI-Public: 30707387023646
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: R1547
• Date Manufacturer Received: 04/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR